NCT03821506

Brief Summary

Background: despite developments a substantial part of patients with depression will only recover slowly. Light therapy from light boxes has shown antidepressant effects but have several limitations: time consuming, only allowing a fixed spectral distribution, only delivered at a specific time-point, and often with inadequate light intensity delivered at the retina. Therefore, we developed a new dynamic lighting system using light fixtures that are built into the room and can change intensity and spectral distribution of light during the 24-hour day. Objectives: the objective of this trial is to assess the beneficial and harmful effects of a newly developed dynamic lighting system using Light Emitting Diodes (LED) -light armatures aiming to mimic sunlight, when installed in the patient rooms of a psychiatric inpatient ward, compared with usual care. Design: the design is a randomised controlled trial with two arms: an active dynamic light trial arm and a usual care arm with blinding of depression outcome, and data analyses. Randomisation will be 1:1. Inclusion criteria: a current episode of a major depressive episode as part of a unipolar or bipolar disorder. Patients with bipolar depression should be in current and recent (minimum two months before admission) mood stabilising treatment, age \> 18 years, informed consent. Exclusion criteria: severe suicidality, abuse of alcohol and / or drugs, actual psychotic state, Young Mania Rating score above 7 or fulfilling diagnostic criteria for a current hypomanic or manic episode. Interventions: the experimental intervention is a dynamic LED-light system in 10 separate patient single rooms with three dynamic lamps: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. The usual care is constant standard LED-light. Primary outcome: score on the Hamilton Depression Rating Scale 6 item version (HAM-D6) scale at week 3 Secondary outcomes: score on the Suicidal Ideation Attribution Scale (SIDAS ) scale at week 3, and score in the Hamilton. Depression Rating Scale 17 item version (HAM-D17) scale at week 3, and score on the World Health Organisation Quality Of Life questionaire abbreviated version (WHOQOL-BREF) at week 3. Trial size: in total, 150 patients. Time schedule: the trial will be submitted for regulatory approvals January 2019, the first participant will be included April 2019, the expected last follow-up of the last participant will be December 2020, the expected last follow-up after 6 months will be June 2021, data will be analysed from June 2021 till September 2021, manuscripts will be prepared from December 2020, and we expect to submit first manuscript December 2021.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started May 2019

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

January 21, 2019

Last Update Submit

February 24, 2026

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale 6 item version

    A scale, consisting of 7 items from the Hamilton depression Rating Scale, measuring severity of depression. Total scores from zero (no depression) to 24 (most severe depression)

    Up to 3 weeks

Secondary Outcomes (3)

  • Score on the SIDAS scale

    Up to 3 weeks

  • Hamilton Depression Rating Scale 17 item version

    Up to 3 weeks

  • WHOQOL-BREF

    Up to 3 weeks

Study Arms (2)

Dynamic light

EXPERIMENTAL

The experimental intervention is the installation of a dynamic LED-light system in 10 separate patient single rooms. The system includes three elements: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. All lamps will have a dynamic, time dependent frequency distribution and intensity of light.

Device: Dynamic Light

Usual care

PLACEBO COMPARATOR

The usual care is constant standard LED-light with two elements: two ceiling mounted lamps and a wall mounted lamp.

Device: Usual care

Interventions

Dynamic LightDEVICE

Dynamic Lighting system

Dynamic light
Usual careDEVICE

Standard lighting system

Usual care

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A current episode of a major depressive episode (DSM-5) as part of a unipolar or bipolar disorder.
  • Patients with bipolar depression should be in current and recent (minimum two months before admission) mood stabilizing treatment
  • Age \> 18 years
  • Informed consent
  • Danish speaking.

You may not qualify if:

  • Severe suicidality
  • Abuse of alcohol and / or drugs
  • Actual psychotic state within last four weeks
  • Actual Young Mania Rating score above 7 or fulfilling diagnostic criteria for a current hypomanic or manic episode
  • Patient is subject to coercive measures of any kind.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatic Hospital Copenhagen

Copenhagen, Denmark, 2100, Denmark

Location

Related Publications (2)

  • Perera S, Eisen R, Bhatt M, Bhatnagar N, de Souza R, Thabane L, Samaan Z. Light therapy for non-seasonal depression: systematic review and meta-analysis. BJPsych Open. 2016 Mar 4;2(2):116-126. doi: 10.1192/bjpo.bp.115.001610. eCollection 2016 Mar.

    PMID: 27703764RESULT

  • Volf C, Aggestrup AS, Petersen PM, Dam-Hansen C, Knorr U, Petersen EE, Engstrom J, Jakobsen JC, Hansen TS, Madsen HO, Hageman I, Martiny K. Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study. BMJ Open. 2020 Jan 26;10(1):e032233. doi: 10.1136/bmjopen-2019-032233.

    PMID: 31988225DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Dynamic Light Scattering

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Scattering, RadiationChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Klaus Martiny, DMSc

    Psychiatic Hospital Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of depression severity assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychiatry

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 29, 2019

Study Start

May 15, 2019

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

We will make data from this study available on reasonable request once the results are published

Locations

DK(1)